Biliary Tract CarcinomaPhase 2NCT06430827
Clinical Study of Irinotecan Hydrochloride Liposome Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma
A Phase 2 study testing irinotecan hydrochloride liposome injection and Capecitabine in people with Biliary Tract Carcinoma, run by Ba Yi at 1 site in China.
Trial summary
To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Carcinoma
- What is being tested?
- irinotecan hydrochloride liposome injection and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient had good compliance, could understand the research process of this study, and signed a written informed consent.
- Age ≥18 years.
- Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer).
- Subjects who had received gemcitabine prior first-line therapy and had not received fluorouracil drugs.
- Subjects who have progressed after receiving previous first-line therapy, relapse within 6 months after the end of (neo) adjuvant therapy is considered as first-line therapy failure.
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
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- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.
- Has a life expectancy of greater than 3 months.
- LVEF≥50%.
- Appropriate organ function is defined as follows: (Hematology and blood biochemistry tests must be completed within 14 days prior to enrollment, and the following criteria are met):
- ANC ≥1.5×10^9/L
- Hb≥90g/L
- PLT ≥100×10^9/L
- total bilirubin ≤1.5 x ULN
- ALT/AST ≤ 2.5 x ULN; When there is liver metastasis, ALT/AST ≤ 5 x ULN
- Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥50mL/min (according to Cockcroft-Gault fórmula)
- Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international standardized ratio (INR) ≤1.5×ULN
- Patients with biliary obstruction should receive adequate biliary drainage.
- Adverse reactions caused by previous treatment must be restored to grade 1 or baseline according to CTCAE5.0 (except for toxicity such as alopecias, grade 2 and below peripheral neuropathy, which can be included after the investigator determines that there is no safety risk).
- non-pregnant or lactating female; Effective contraception should be used by female/Male of childbearing age during the study period and for 6 months after the end of study treatment.
- There were no contraindications for the use of irinotecan liposomes and capecitabine.
Who cannot join
- Patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and skin basal cell carcinoma).
- Uncontrolled pleural effusion or ascites.
- Any known brain or meningeal metastases.
- Subjects were co-administering a potent CYP3A4 inducer within 3 weeks prior to first dosing, or a potent CYP3A4 inhibitor or a potent UGT1A1 inhibitor within 3 weeks prior to first dosing.
- Subjects underwent large organ surgery (except needle biopsy, central venous catheterization, port catheterization, stenting for relief of biliary obstruction, percutaneous hepatobiliary drainage, and cholecystostomy) or an elective surgical program within 4 weeks before the first dose of the study drug.
- Active, uncontrolled bacterial, viral, or fungal infections with systemic treatment, defined as persistent signs/symptoms associated with infection that do not go away despite the use of appropriate antibiotics, antiviral therapy, and/or other treatment, including patients with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
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- Patients who are known to have dihydropyridine dehydrogenase (low activity) or deficiency.
- There are serious concomitant diseases: such as uncontrolled diabetes after hypoglycemic drug treatment, uncontrolled hypertension, serious cardiovascular and cerebrovascular disease, kidney failure, liver failure, uncontrolled epilepsy, central nervous system disease or mental disorder history, clear gastrointestinal bleeding tendency, intestinal paralysis, intestinal obstruction, etc.
- Grade 1 diarrhea with an increase in the number of stools > 4 times per day compared to baseline; The moderate and severe effluents from stoma increased; Limited activities of daily living with the aid of tools or even self-rational activities of daily living; Life-threatening; Need urgent medical attention.
- Had participated in other clinical investigators within 4 weeks before enrollment.
- Unsuitable for participation in the trial by the investigator assessed.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medicalcollege Hospital
Beijing
Yi Ba, PHD, +86 010 69158705, bayipumch@aliyun.com
About this study
Official title: Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma.
To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma.
- Conditions
- Biliary Tract Carcinoma
- Being tested
- irinotecan hydrochloride liposome injection, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irinotecan hydrochloride liposome injectionDrug
Also called duoenyi
rinotecan hydrochloride liposome injection (70mg/m^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
CapecitabineDrug
Also called Kapeitabin
Capecitabine (1000 mg/m^2) will be administered orally in a 2-week treatment cycle, twice a day from day 1 to day 10 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine therapy in a 2-week treatment cycle. Receives: Drug: irinotecan hydrochloride liposome injection; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
To evaluate the efficacy of anti-tumor
Measured: baseline up to approximately 6 months
Secondary outcomes (3)
Objective response rate (ORR)
To evaluate the efficacy of anti-tumor
Measured: baseline up to approximately 6 months
Overall survival (OS)
To evaluate the efficacy of anti-tumor
Measured: baseline up to approximately 12 months
Quality of life (QoL)
To identify the quality of life by QLQ-C30（V3.0）
Measured: baseline up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start30 Jun 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ba Yi
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor-investigator, Ba Yi, Peking Union Medical College Hospital
- Investigators
- Yi Ba, Principal investigator, PEKING UNION MEDICALCOLLEGE HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430827
- Sponsor's protocol ID
- CSPC-DNY-BTC-02
- Status last verified
- May 2024
- First submitted
- 15 Apr 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma.
- ClinicalTrials.gov ID
- NCT06430827
- Acronym / sponsor ID
- CSPC-DNY-BTC-02
- Conditions
- Biliary Tract Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ba YiUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: irinotecan hydrochloride liposome injection, Drug: CapecitabinePatients will receive irinotecan hydrochloride liposome injection combined with Capecitabine therapy in a 2-week treatment cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- The patient had good compliance, could understand the research process of this study, and signed a written informed consent.
- Age ≥18 years.
- Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer).
- Subjects who had received gemcitabine prior first-line therapy and had not received fluorouracil drugs.
- Subjects who have progressed after receiving previous first-line therapy, relapse within 6 months after the end of (neo) adjuvant therapy is considered as first-line therapy failure.
Key exclusion criteria (11 listed)
- Patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and skin basal cell carcinoma).
- Uncontrolled pleural effusion or ascites.
- Any known brain or meningeal metastases.
- Subjects were co-administering a potent CYP3A4 inducer within 3 weeks prior to first dosing, or a potent CYP3A4 inhibitor or a potent UGT1A1 inhibitor within 3 weeks prior to first dosing.
- Subjects underwent large organ surgery (except needle biopsy, central venous catheterization, port catheterization, stenting for relief of biliary obstruction, percutaneous hepatobiliary drainage, and cholecystostomy) or an elective surgical program within 4 weeks before the first dose of the study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| irinotecan hydrochloride liposome injectionAlso: duoenyirinotecan hydrochloride liposome injection (70mg/m^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle. | Drug | Experimental |
| CapecitabineAlso: KapeitabinCapecitabine (1000 mg/m^2) will be administered orally in a 2-week treatment cycle, twice a day from day 1 to day 10 of each cycle | Drug | Experimental |
Primary outcome
Progression-free survival (PFS)
Time frame: baseline up to approximately 6 months
To evaluate the efficacy of anti-tumor
3 secondary outcomes
Objective response rate (ORR)
Time frame: baseline up to approximately 6 months
Overall survival (OS)
Time frame: baseline up to approximately 12 months
Quality of life (QoL)
Time frame: baseline up to approximately 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Ba principal investigator
PEKING UNION MEDICALCOLLEGE HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing irinotecan hydrochloride liposome injection and Capecitabine in people with Biliary Tract Carcinoma, run by Ba Yi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Ba, PHD (+86 010 69158705, bayipumch@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: baseline up to approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.